The FDA today labeled Cook Medical‘s recall of its central venous catheter and pressure monitoring sets and trays as Class I over issues with tip splitting and separation.
The devices being recalled are used to monitor pressure in a patient’s vein or artery, to sample blood and to administer drugs or fluids.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The devices are being recalled over issues with device tips splitting or separating from the catheters due to a manufacturer error, which could allow the tip to enter a patients blood stream. Tips and pieces entering the blood stream could cause serious injury or death and requires medical interventions to extract, the FDA said.
The recall is for the Bloomington, Ind.-based company’s single lumen central venous catheter sets and trays, single lumen pressure monitoring sets and trays, femoral artery pressure monitoring catheter sets and trays and radial artery pressure monitoring catheter sets and trays, according to the FDA.
A total of 12,516 devices in the U.S. are being recalled, according to the FDA, manufactured between April 9, 2015 and October 22, 2015 and distributed between April 24, 2015 and October 23, 2015.
Cook Medical said it sent a letter to customers with the devices in January advising them to quarantine and return the affected products as soon as possible, and to report any adverse events.
Last February, Cook Medical expanded its Class I recall for beacon tip angiographic catheters to include additional lots, according to an FDA press release.
Cook Medical’s Beacon Tip Angiographic Catheters are used to inject contrast die into blood vessels in the heart to prepare for cardiac angiograms used to diagnose heart conditions.
The recall was initially filed in July over issues with tip splitting or separation of the device which can lead to the loss of function and separation that may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.